Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this research study is to investigate the cognitive (thinking, memory, knowledge, intelligence) side effects of two medications commonly used to treat overactive bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease; Overactive Bladder	Drug: Oxybutynin and darifenacin	Not Applicable

Detailed Description:

This study will be a double-blinded cross-over clinical trial design to assess the prevalence of cognitive effects, the efficacy, and the effect on quality of life (QOL) of two anticholinergic medications commonly used in the treatment of overactive bladder (OAB): oxybutynin and darifenacin. This will be done by use of a well-established and validated computer-based cognitive battery. Secondary endpoints will assess efficacy of anticholinergic therapy on symptoms of OAB via QOL questionnaire and participant urinary diaries.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study
Study Start Date :	May 2009
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	September 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Arm 1; crossover design	Drug: Oxybutynin and darifenacin; Participants with overactive bladder will take each medication for 4 weeks.

Outcome Measures

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Primary Outcome Measures :

1. compare cognitive side effects [ Time Frame: 10 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Diagnosis of idiopathic PD (ICD9=332.0)
• MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.

• Urological work-up within 3 months of enrollment to:

  • Rule out treatable causes of urinary symptoms

    • Urinalysis (UA)
    • Post-void residual ultrasound (PVR)
    • Urinary cytology

  • Documented symptoms OAB on screening 3-day voiding diary:

    • Average of 1 urgency episode / 24 hours, and
    • Average of 8 micturitions / 24 hours
    • Subjective complaints of symptoms for 3 months

Exclusion Criteria:

• Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
• Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
• Exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome P450 enzyme, primarily CYP3A4). These include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
• Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
• Uncontrolled narrow angle glaucoma
• History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
• History of hepatic or renal impairment
• History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
• Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	Jayne R Wilkinson, MD	VA Medical Center, Philadelphia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00892450 History of Changes
Other Study ID Numbers:	01143
First Posted:	May 4, 2009
Last Update Posted:	October 3, 2014
Last Verified:	October 2014

Keywords provided by VA Office of Research and Development:

Overactive bladder symptoms; Parkinson's disease; darifenacin; oxybutynin; cognition

Additional relevant MeSH terms:

Parkinson Disease; Urinary Bladder, Overactive; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations	Signs and Symptoms; Oxybutynin; Darifenacin; Cholinergic Antagonists; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Muscarinic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents